Who is the manufacturer of USCI IDEAL PTCA KIT?

Ryder Intl. Corp. filed the 510(k) submission for USCI IDEAL PTCA KIT (K953522).

What is the FDA product code for USCI IDEAL PTCA KIT?

MAV. It is classified under 21 CFR 870.1650 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for USCI IDEAL PTCA KIT?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like USCI IDEAL PTCA KIT?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

USCI IDEAL PTCA KIT

K953522 · Ryder Intl. Corp. · MAV · Apr 17, 1996 · Cardiovascular

Device Facts

Record ID	K953522
Device Name	USCI IDEAL PTCA KIT
Applicant	Ryder Intl. Corp.
Product Code	MAV · Cardiovascular
Decision Date	Apr 17, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1650
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Ryder device is intended for single use inflating of a balloon catheter, monitoring the pressure within the catheter and deflating the balloon catheter during angioplasty procedures.

Device Story

Ryder Balloon Catheter Inflation Syringe; manual screw-type plunger mechanism with locking lever and rotating palm grip; 20 cc fluid capacity; operating pressure range vacuum to 30 bars; includes manometer for pressure monitoring and high-pressure connecting tube; used by clinicians during angioplasty; provides controlled inflation/deflation of balloon catheters; enables precise pressure management; single-use device.

Clinical Evidence

Bench testing only; USP material biocompatibility testing performed on patient-contacting components.

Technological Characteristics

Plastic syringe construction; screw-type plunger; locking lever; rotating palm grip; integrated manometer; high-pressure connecting tube; 20 cc capacity; 0-30 bar pressure range; single-use.

Indications for Use

Indicated for patients undergoing angioplasty procedures requiring balloon catheter inflation, pressure monitoring, and deflation.

Regulatory Classification

Special Controls

*Classification.* Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

Merit Medical Systems Monarch™ Balloon Catheter Inflation Syringe

Related Devices

K962611 — BARD EAGLE INFLATION DEVICE · Ryder Intl. Corp. · Oct 21, 1996
K130566 — BASIXTOUCH · Merit Medical Systems, Inc. · Jun 19, 2013
K122321 — BASIXCONPAK ANALOG INFLATION SYRINGE · Merit Medical Ireland, Ltd. · Dec 19, 2012
K040138 — VICEROY INFLATION DEVICE · Merit Medical Systems, Inc. · Feb 13, 2004
K143522 — Presto Inflation Device · C.R. Bard, Inc. · Jan 12, 2015

Submission Summary (Full Text)

{0} 1953522 # XII. SUMMARY OF SAFETY AND EFFECTIVENESS Date of Preparation: July xx, 1995 Device Name: Ryder Balloon Catheter Inflation Syringe Classification Name: Balloon Catheter Inflation Syringe Manufacturer: Ryder International Corporation, 100 Curt Francis Road, Arab, AL 35016 Contact: Mr. D. Clark, Ryder International Corporation, 100 Curt Francis Road, Arab. AL 35016 Predicate: Merit Medical Systems Monarch™ Balloon Catheter Inflation Syringe ## Device Description/ Intended Use: The Ryder Balloon Catheter Inflation Device consists of a plastic syringe with a screw-type plunger and a locking lever and rotating palm grip that control the plunger, a manometer to measure pressure and a high pressure connecting tube. The Ryder Device has a fluid capacity of 20 cc. and an operating pressure range of vacuum to 30 bars. The Ryder device is intended for single use inflating of a balloon catheter, monitoring the pressure within the catheter and deflating the balloon catheter during angioplasty procedures. ## Summary of Safety Testing: The materials of the device which contact the contrast solution in use have been tested using USP guidelines and the results of these studies indicate that the product is safe for its intended use. 0068 757